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Clinical Coverage Guidelines

Clinical Coverage Guidelines (CCGs)


These guidelines apply to absorbent products used for managing urinary incontinence in pediatric, adult, and elderly persons.

Acne vulgaris (acne) is the formation of comedones, papules, pustules, nodules, and/or cysts as a result of obstruction and inflammation of pilosebaceous units (hair follicles and their accompanying sebaceous gland).

Age-related macular degeneration (AMD) is a common eye condition and a leading cause of vision loss among people age 50 and older.

Adult Medical Day Health (AMDH) and Pediatric Medical Day Health (PMDH) services are concerned with the fulfillment of the health needs of eligible members who could benefit from a health services alternative to total institutionalization.

Medically appropriate air ambulance transportation is a covered service regardless of the State or region in which it is rendered.

Automated ambulatory blood pressure monitoring (ABPM) devices consist of an inflatable arm cuff with pressure regulators and valves to measure blood pressure, a cuff microphone or sound transducer and microprocessor to detect and interpret blood pressure sounds or oscillations, mechanisms for programming and recording blood pressure readings, batteries for operating the device, and, in the case of semiautomatic devices, an inflation bulb.

Behavior analysis is a natural-science approach to understanding the behavior of individuals.

Aquatic therapy is an active therapeutic intervention that takes place in water.


BHOS services are overlay services provided to children under 21 who reside in specifically licensed residential settings (provider type 05) in Florida.

OnabotulinumtoxinA (Botox) injections have been found to be effective in individuals with a variety of medical conditions.

In 2010, over 207,000 new cases of breast cancer among women in the United States while 39,840 died from the disease.

The most common reason for breast reconstruction is to repair defects caused by breast cancer. Breast cancer is the second most frequently occurring cancer in the United States.

Johns Hopkins Health Library defines burns as a type of painful wound caused by thermal, electrical, chemical, or electromagnetic energy.


Over 60 million Americans have one or more forms of cardiovascular disease, and cardiovascular disease is the leading cause of morbidity and mortality in the United States for both men and women, accounting for > 50% of all deaths.

Chelation therapy is an established treatment for heavy metal poisoning.

The FDA assigns a special identifier number that corresponds to each device granted an investigational device exemption (IDE).

Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol.

The technique for computed tomography colonography (CTC) involves the following steps: (1) bowel cleansing; (2) colon insufflation; (3) image acquisition; and (4) image processing and interpretation (Isenberg et al., 2003).

Diabetes mellitus is characterized by hyperglycemia due to impaired pancreatic insulin secretion or inefficient use of insulin by the body.

Cranial orthotic devices are used in infants for the treatment of positional plagiocephaly, deformation of the head that results from external pressure applied to the soft infant skull.

The American College of Physicians and the American Pain Society (ACP/APS) published a joint clinical guideline for the diagnosis and treatment of low back pain; spinal manipulation is recommended for patients who do not improve with self-care options.

Craniosynostosis is a condition in which the sutures close too early, causing problems with normal brain and skull growth.

Crisis Stabilization Unit Services is a facility-based program for members with urgent/emergent needs who require crisis stabilization services in a safe, structured setting.


Some medical conditions may result in a condition called lipoatrophy, characterized by facial wasting of fat under the skin of the face and other parts of the body.

Early identification of developmental disorders is critical to the well-being of children and their families. This is an integral function of the primary care medical home and an appropriate responsibility of all pediatric health care professionals.

Diabetes is a condition that causes high levels of glucose in the blood.

Genetic testing can be performed for several reasons; predominantly among these reasons are 1) using genetic testing as a diagnostic tool, and 2) using testing as a mechanism for predicting the presence of a specific disease in those with a familial history.

Diaphragmatic/phrenic nerve stimulator devices are indicated for certain ventilator-dependent individuals who lack voluntary control of their diaphragm muscles to enable independent breathing without the assistance of a mechanical ventilator for at least four continuous hours a day.

States are required to arrange for and cover under the EPSDT benefit any Medicaid covered service listed in Section 1905(a) of the Act if that treatment or service is determined to be medically necessary to correct or ameliorate defects and physical and mental illnesses or conditions.

The U.S. Food and Drug Administration (FDA) approved Duopa (a formula of carbidopa and levodopa) to treat a small subset of patients with advanced Parkinson’s disease.


The Electro-Oculography (EOG) is an electrophysiological test of function of the outer retina and retinal pigment epithelium (RPE) in which the change in the electrical potential between the cornea and the ocular fundus is recorded during successive periods of dark and light adaptation.

Evidence from the reviewed studies indicates that exhaled NO demonstrates moderate to good accuracy in diagnosing asthma and may be useful in predicting and monitoring inflammatory responses indicative of asthma exacerbation before and during anti-inflammatory treatment.

The FDA describes Duchenne muscular dystrophy (DMD) as a rare genetic disorder characterized by progressive muscle deterioration and weakness.

The augmented diastolic pressure and retrograde aortic flow appear to improve myocardial perfusion, while systolic unloading appears to reduce cardiac workload and oxygen requirements.

Sudden cardiac death (SCD) is typically defined as unanticipated death due to cardiac causes that occur within 1 hour of the onset of acute symptoms.


Colorectal cancer (CRC) is the third most common cancer in both men and women in the United States.

Uterine fibroids (or leiomyomas) are benign soft tissue neoplasms that arise from smooth muscle. These lesions can develop wherever smooth muscle is present, but malignant transformation probably does not occur.

Ankyloglossia (tongue-tie) develops when the inferior lingual frenulum attaches to the bottom of the tongue and restricts its movement.


Gender reassignment therapy, either as male-to-female transsexuals (transwomen) or as female-to-male transsexuals (transmen), consists of medical and surgical treatment that changes primary or secondary sex characteristics.

Genetic profiling of tumors allows breast cancers to be classified based on their expression of specific genes that are related to the clinical behavior of the disease.

Alzheimer’s disease (AD), which is the most common form of dementia, is a progressive, neurogenerative disorder characterized by amyloid plaques and neurofibrillary tangles in the brain.

Given that CF screening has been a routine part of reproductive care for women since 2001, it is prudent to determine if the patient has been previously screened before ordering CF screening that may be redundant.

Factor V Leiden is the name of a specific mutation that results in thrombophilia, or an increased tendency to form abnormal blood clots in blood vessels.

FAP and AFAP are inherited in an autosomal dominant manner. Approximately 75–80% of individuals with these conditions have an affected parent.

Fragile X syndrome is the most common cause of inherited mental retardation and is due to a mutation in the X-linked FMR1 gene.

Hereditary nonpolyposis colorectal cancer (HNPCC) is one of several familial syndromes that is associated with a high risk of colorectal adenocarcinoma.

Long QT syndrome (LQTS) is a disorder of the heart's electrical system. It is characterized by prolongation of the QT interval.

NF1 is inherited in an autosomal dominant fashion. In approximately one half of patients, the condition is caused by a new mutation in that conception.

Two major breast cancer predisposition genes, known as the breast cancer 1 susceptibility gene (BRCA1) and breast cancer 2 susceptibility gene (BRCA2), have been implicated in up to 40% of hereditary breast cancers, and it is estimated that mutations in BRCA1 and BRCA2 account for 5% to 10% of all breast cancers.

TSC is a variable multisystem disorder characterized by hamartomas that result in abnormalities of the skin (including hypomelanotic macules, facial angiofibromas, shagreen patches, fibrous facial plaques, and ungual fibromas), brain (including cortical tubers and subependymal nodules), kidneys (including angiomyolipomas and renal cysts), and heart (including rhabdomyomas and arrhythmias).

Growth Hormone Deficiency (GHD) is a rare disorder characterized by the inadequate secretion of growth hormone (GH) from the anterior pituitary gland, a small gland located at the base of the brain that is responsible for the production of several hormones.


Hearing aids are electronic amplifying devices designed to bring sound more effectively into the ear.

Social Security describes home health as a service furnished to an individual, by a home health agency, with a plan of care established and periodically reviewed by a physician, on a visiting basis in the individual’s place of residence.

Hyperbilirubinemia is the most common condition requiring medical attention in newborns.


Inherited immunodeficiency disorders that affect B cells include hypogammaglobulinemia (which usually leads to respiratory and gastrointestinal infections) and agammaglobulinemia (which results in severe infections early in life, and is often deadly). Inherited immunodeficiency disorders that affect T cells may cause repeated Candida (yeast) infections.

In the United States, approximately 70,000 or 10% of all strokes are due to intracranial atherosclerotic disease (ICAD), blockage of the small arteries of the brain by fatty deposits.


Hemophilia A, factor VIII deficiency, is a recessive X-chromosome linked inherited coagulation factor deficiency that result in a lifelong bleeding disorder.

The individual has engaged in an act of sexual abuse to another individual within the past 90 days (or more, if delay occurs due to delayed discovery or legal system.) or patient has a history of having committed a sexual offense, is in outpatient treatment, and is demonstrating behavior suggesting to the treating clinician that new offending behavior is imminent.


Liver biopsy is a fundamentally important tool in the management of patients with liver disease, important for diagnosis as well as staging of liver disease and its use is recommended until clearly superior methodologies are developed and validated.

A study by Winner, et al. (2012) shows that long-acting reversible contraception (LARC) is more effective than other methods (e.g., pill, pact or ring).

On December 19, 2017 The US Food and Drug Administration (FDA) approved Luxturna (voretigene neparvovec-rzyl), a new gene therapy to treat a rare form of inherited vision loss that can lead to blindness.


Makena® (hydroxyprogesterone caproate injection) is a progestin medication indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

The neonatal risks of late preterm (34 0/7 – 36 6/7 weeks of gestation) and early-term (37 0/7 – 38 6/7 weeks of gestation) births are well established.

Microvolt T-wave Alternans (MTWA) testing is a non-invasive diagnostic test that detects minute electrical activity in a portion of the electrocardiogram (EKG) known as the T-wave.


NMES involves the use of a device which transmits an electrical impulse to the skin over selected muscle groups by way of electrodes.


Observation care is a well-defined set of specific, clinically appropriate services, which include ongoing short term treatment, assessment, and reassessment, that are furnished while a decision is being made regarding whether patients will require further treatment as hospital inpatients or if they are able to be discharged from the hospital.

Multiple sclerosis (MS) is an immune-mediated disease in which an abnormal response of the body’s immune system is directed against the central nervous system, brain, spinal cord and optic nerves.

Prostate cancer is the most common cancer among American males. An estimated 233,000 new cases were diagnosed in 2014 and 29,480 deaths resulted from prostate cancer.

The term "feeding disorder" refers to a condition in which a patient is unable or refuses to eat, or has difficulty eating, resulting in failure to grow normally.

Orthognathic surgery is the surgical correction of abnormalities of the mandible, maxilla, or both.

Of the estimated 5.6 million fractures that occur annually in the United States, approximately 5% to 10% will demonstrate signs of delayed or impaired healing.


The RedPath Integrated Pathology (Pittsburgh, PA) PathFinderTG test is not a single test, but rather, is an advanced pathology service that includes microdissection, selection of regions to be analyzed, analysis of these regions using a variety of molecular tests (topographic genotyping), and expert pathologist interpretation of the results along with what is known about the particular case.

Obstructive sleep apnea syndrome (OSAS) is a disorder of breathing in which prolonged partial upper airway obstruction and/or intermittent complete obstruction occurs during sleep disrupting normal ventilation and normal sleep patterns.

Amplification with hearing instruments should be considered for a child who demonstrates a significant hearing loss, including sensorineural, conductive, or mixed hearing losses of any degree.

Diabetes mellitus is characterized by hyperglycemia due to impaired pancreatic insulin secretion or inefficient use of insulin by the body.

Developmental disability is defined as an inability to perform age-appropriate functional skills as indicated by standard test scores less than 85, scaled score less than 7, percentile less than 16, Z-score less than −1.00 or developmental quotient (DQ) less than 80.2.

The Centers for Medicare & Medicaid Services concluded that the available evidence does not demonstrate that pharmacogenomic testing of CYP2C9 or VKORC1 alleles to predict warfarin responsiveness improves health outcomes in Medicare beneficiaries.

Warfarin sodium is an orally administered anticoagulant drug that is marketed most commonly as Coumadin®.

Post–acute care refers to a wide range of services, which include skilled nursing facilities, inpatient rehabilitation facilities, home health aides, outpatient physical and occupational therapy, and long-term care facilities.

Prolastin-C is an Alpha1-Proteinase Inhibitor that is indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary alpha1-antitrypsin deficiency.

Psychosocial rehab (PSR) encompasses community-based or clinic-based but community-focused services designed to assist adults in strengthening or regaining skills designed to help them achieve their self-determined rehabilitation goals in living, working, educational or social environments and the development of environmental supports necessary to thrive in the community with the least amount of professional intervention possible.


On May 5, 2017 The U.S. Food and Drug Administration approved Radicava® (edaravone) as a treatment for patients with ALS.

On October 15, 2018, the United States Food and Drug Administration (FDA) approved Revcovi™ (elapegademaselvlr), a second-generation medication therapy for ADA.

Reduction mammoplasty is the surgical reduction of breast size. It was developed as a means of alleviating physical and emotional symptoms associated with excessive breast size and breast ptosis.

HP Acthar Gel is an adrenocorticotropic hormone (ACTH) analogue indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age.

Respite Care is short-term inpatient care provided to the individual only when necessary to relieve the family members or other persons caring for the individual at home.

Beneficiaries may have a combination of developmental, neurological and medical conditions necessitating the need for certain dental services to be provided in an operating room as an outpatient hospital service.


Fecal incontinence is defined as the involuntary loss of solid or liquid feces.

SBIRT (Screening Brief Intervention Referral to Treatment) is a comprehensive, integrated, public health approach to the delivery of early intervention and treatment services for persons with substance use disorders, as well as those who are at risk of developing these disorders.

Soliris® (eculizumab) is a complement inhibitor which inhibits the terminal part of the complement cascade, a part of the immune system that, when activated in an uncontrolled manner, plays a role in serious rare disorders like paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS) and anti-acetylcholine receptor (AchR) antibody-positive myasthenia gravis (MG).

Speech therapy is the study, diagnosis and treatment of speech, language and communication in people of all ages to enable them to communicate to the best of their ability.

Spinal Muscular Atrophy (SMA) disorders are characterized by degeneration of the anterior horn cells in the spinal cord and motor nuclei in the lower brainstem.

Stem-cell transplantation refers to the transplantation of hematopoietic stem cells (HSCs) into a patient.

Pectus excavatum is a chest wall deformity in which a depression of the sternum (funnel chest) occurs. Pectus carinatum, or pigeon breast, is another chest wall deformity characterized by an anterior protrusion of the sternum and costal cartilages.


Targeted Case Management Services (TCM) are direct outpatient services delivered in the member’s home, residence of another type, or within a community setting.

Telehealth and telemedicine are often used interchangeably; WellCare uses the following distinction

Implantable testosterone pellets may be indicated as second-line testosterone replacement therapy for males.

Autism spectrum disorder (ASD) is a range of complex neurodevelopment disorders, characterized by social impairments, communication difficulties, and restricted, repetitive, and stereotyped patterns of behavior.

DiGeorge syndrome (DGS) is a disorder in which there is a defect in the development of the pharyngeal pouch system. The syndrome is most commonly caused by a chromosomal deletion at 22q11.2.

The Centers for Medicare and Medicaid Services (CMS) has determined that the evidence is adequate to conclude that counseling to prevent tobacco use, which is recommended with a grade of A by the U.S. Preventive Services Task Force (USPSTF) for all adults and pregnant women who use tobacco, is necessary for prevention of illness or disability and is appropriate for individuals entitled to benefits under Part A or enrolled under Part B.

The health plan may implement directed quality improvement initiatives that require the coordination and use of community resources such as transportation services that may or may not be a component of the member’s benefit structure.

The National Conference of State Legislatures (2014) states that traumatic brain injury (TBI) is a disruption in the normal functioning of the brain due to a bump, blow, jolt or penetrating head injury.

Nausea and vomiting of pregnancy, commonly known as “morning sickness,” affects approximately 80 percent of pregnant women.

Lymphedema is an accumulation of lymphatic fluid in the interstitial tissue, principally in the subcutaneous fatty issues.

Trogarzo™ (ibalizumab) is a humanized monoclonal antibody developed for the treatment of multidrug resistant HIV-1 infection.


Psychological testing is a covered benefit in accordance with the member’s benefit plan, and when indicated the WellCare, Inc.


VANTAS® (histrelin implant) is a sterile, non-biodegradable, diffusion-controlled HYDRON® polymer reservoir containing histrelin acetate, a synthetic nonapeptide analog of the naturally occurring gonadotropin releasing hormone (GnRH), also known as luteinizing hormone releasing hormone (LH-RH), possessing a greater potency than the natural sequence hormone.


Wound care includes, but is not limited to ulcers, pressure ulcers, open surgical sites, fistulas, tube sites and tumor erosion sites when the skills of a licensed therapist, qualified wound care nurse, nurse or physician/physician extender are required to safely and effectively provide the care necessary for their treatment.


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Last Updated On: 12/23/2016